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Fertility and Sterility Mar 2019To synthesize the evidence on the most effective medications for the relief of intrauterine device (IUD) insertion-related pain. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To synthesize the evidence on the most effective medications for the relief of intrauterine device (IUD) insertion-related pain.
DESIGN
Systematic review and network meta-analysis of randomized controlled trials (RCTs).
SETTING
Not applicable.
PATIENT(S)
Patients undergoing IUD insertion who received different medications for pain relief versus those who received placebo.
INTERVENTION(S)
Electronic search in the following bibliographic databases: Medline via PubMed, SCOPUS, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), and ScienceDirect.
MAIN OUTCOME MEASURE(S)
Visual analog scale (VAS) pain score during tenaculum placement, IUD insertion, and 5 to 20 minutes after insertion, the score of easiness of insertion and the need for additional analgesics.
RESULT(S)
The present review included 38 RCTs (n = 6,314 patients). The network meta-analysis showed that lidocaine-prilocaine cream (genital mucosal application) statistically significantly reduced pain at tenaculum placement compared with placebo (mean difference -2.38; 95% confidence interval, -4.07 to -0.68). In the ranking probability order, lidocaine-prilocaine cream ranked the highest in reducing the pain at tenaculum placement, followed by lidocaine (paracervical). Similarly, lidocaine-prilocaine cream ranked as the highest treatment in pain reduction during IUD insertion, followed by lidocaine (paracervical).
CONCLUSION(S)
Lidocaine-prilocaine cream is the most effective medication that can be used for IUD insertion-related pain. Other medications are not effective.
Topics: Administration, Intravaginal; Anesthetics, Local; Contraception; Female; Humans; Intrauterine Devices; Lidocaine, Prilocaine Drug Combination; Pain; Pain Measurement; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30611553
DOI: 10.1016/j.fertnstert.2018.11.012 -
Journal of Anesthesia Apr 2019Although many drugs or interventions have been studied to manage catheter-related bladder discomfort (CRBD), their comparative effectiveness is unknown. We attempted to... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Although many drugs or interventions have been studied to manage catheter-related bladder discomfort (CRBD), their comparative effectiveness is unknown. We attempted to assess the comparative effectiveness of the strategies to manage CRBD in patients undergoing urologic surgery including amikacin, solifenacin, darifenacin, butylscopolamine, dexmedetomidine, gabapentin, glycopyrrolate, ketamine, oxybutynin, resiniferatoxin, tolterodine, tramadol, caudal block, dorsal penile nerve block, lidocaine-prilocaine cream.
METHODS
We performed an arm-based network meta-analysis including 29 trials with 2841 participants. Goodness of model fit was evaluated by deviance information criteria (DIC). The incidence of CRBD at 0, 1, and 6 h after surgery and the incidence of moderate to severe CRBD at 0, 1, and 6 h after surgery were compared.
RESULTS
Random effect model was selected according to DIC. Most of the drugs significantly decreased the incidence of CRBD except amikacin, tramadol at 0 and 1 h after surgery. Dexmedetomidine, solifenacin, caudal block, dorsal penile nerve block, resiniferatoxin, and gabapentin 1200 mg p.o. significantly decreased the incidence of CRBD at 6 h after surgery (gabapentin 1200: Odds ratio [OR] 0.02; SUCRA 95.6). Dexmedetomidine and tolterodine significantly decreased the incidence of moderate to severe CRBD at 0, 1, and 6 h after surgery (tolterodine at 6 h: OR 0.05; SUCRA 73.7).
CONCLUSIONS
Gabapentin was ranked best regarding the overall incidence of CRBD, while tolterodine was ranked best in reducing the severity of CRBD. However, a firm conclusion cannot be made from our analysis due to small-study number and heterogeneity regarding study setting and outcome measurement.
Topics: Humans; Network Meta-Analysis; Pain, Postoperative; Postoperative Period; Urinary Catheterization; Urinary Catheters
PubMed: 30603826
DOI: 10.1007/s00540-018-2597-2 -
Pediatrics Jan 2019: media-1vid110.1542/5852339542001PEDS-VA_2018-1173 CONTEXT: The eutectic mixture of lidocaine (EMLA) cream has been used to reduce the pain during venipuncture in... (Meta-Analysis)
Meta-Analysis
UNLABELLED
: media-1vid110.1542/5852339542001PEDS-VA_2018-1173 CONTEXT: The eutectic mixture of lidocaine (EMLA) cream has been used to reduce the pain during venipuncture in infants.
OBJECTIVE
To determine the efficacy and safety of EMLA in infants <3 months of age requiring venipuncture in comparison with nonpharmacological interventions in terms of pain reduction, change in physiologic variables, and methemoglobinemia.
DATA SOURCES
Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and gray literature were searched from inception to August 2017, without language restrictions.
STUDY SELECTION
We selected randomized controlled trials in which researchers compared EMLA with nonpharmacological interventions.
DATA EXTRACTION
Two reviewers independently performed abstract screening and full-text review, and extracted the data and assessed the risk of bias.
RESULTS
Ten randomized controlled trials (907 infants) were included. EMLA revealed little or no effect in reduction of pain (standardized mean difference: 0.14; 95% confidence interval [CI]: -0.17 to 0.45; 6 trials, = 742; moderate-quality evidence) when EMLA was compared with sucrose, breastfeeding, or placebo. In comparison with placebo, EMLA revealed a small-to-moderate effect on increasing methemoglobin levels (mean difference: 0.35; 95% CI: 0.04 to 0.66; 2 trials, = 134; low-quality evidence). There was an increased risk of blanching of the skin in the EMLA group (relative risk: 2.63; 95% CI: 1.58 to 4.38; 2 trials, = 123; I = 84%, very low-quality evidence).
LIMITATIONS
Our results may not be applicable to older infants.
CONCLUSIONS
EMLA reveals minimal benefits in terms of reduction of pain due to venipuncture procedure in comparison with placebo and no benefit in comparison with sucrose and/or breastfeeding. Moreover, it produced an elevation in methemoglobin levels and skin blanching.
Topics: Anesthetics, Combined; Humans; Infant; Lidocaine, Prilocaine Drug Combination; Pain; Pain Management; Pain Measurement; Phlebotomy; Skin Diseases; Treatment Outcome
PubMed: 30587535
DOI: 10.1542/peds.2018-1173 -
The Journal of Maternal-fetal &... Mar 2020Perineal trauma is a common problem that may affect women during vaginal delivery; this trauma can be either spontaneous (tear) or intentional (episiotomy). When repair... (Comparative Study)
Comparative Study Meta-Analysis
Lidocaine-prilocaine cream versus local infiltration anesthesia in pain relief during repair of perineal trauma after vaginal delivery: a systematic review and meta-analysis.
Perineal trauma is a common problem that may affect women during vaginal delivery; this trauma can be either spontaneous (tear) or intentional (episiotomy). When repair of perineal trauma is required, adequate analgesics must be obtained. Topical products as lidocaine-prilocaine (EMLA) cream is one of the suggested methods, but still there is lack of evidence with regard to its efficacy and safety. The aim of this review is to assess the evidence of utilizing EMLA cream in comparison to local perineal infiltration anesthesia for pain control during perineal repair after vaginal delivery. Medline, Embase, Dynamed Plus, ScienceDirect, TRIP database, ClinicalTrials.gov and the Cochrane Library were searched electronically from January 2006 to May 2018 for studies investigating the effect of lidocaine-prilocaine cream in relieving pain during repair of perineal trauma. All randomized controlled trials assessing effect of lidocaine-prilocaine cream versus local infiltration anesthesia in relieving pain during repair of perineal trauma were considered for this meta-analysis. Fifteen studies were identified of which four studies deemed eligible for this review. Quality and risk of bias assessment was performed for all studies. Two researchers independently extracted the data from the individual articles and entered into RevMan software. The weighted mean difference (WMD) and 95% confidence interval (CI) was calculated. Statistical heterogeneity between studies was assessed by the Higgins chi-square and (I) statistics. When heterogeneity was significant, a random-effects model was used for meta-analysis. Otherwise, the fixed effect meta-analysis was used when there was no significant heterogeneity. Pooled analysis of result in "pain score" was insignificant between the two groups (WMD -1.11; 95% CI (-2.55 to 0.33); = .13). Furthermore, the use of additional analgesia showed no statistically significant difference between the two groups (WMD 1.34; 95% CI (0.66-2.71), = .42). Regarding patient satisfaction, an overall analysis of three studies showed significant results favoring EMLA cream group users (WMD 4.65; 95% CI (1.96-11.03), = .0005). The pooled analysis of the outcome "duration of repair" showed the significantly shorter duration of repair in EMLA cream users ( = 92) than local infiltration anesthesia ( = 95) (1.72 min; 95% CI (-2.76 to -0.67), = .001). This meta-analysis suggests that topical lidocaine-prilocaine cream gives comparable results in reducing pain during perineal repair after vaginal delivery.
Topics: Anesthesia, Local; Anesthetics, Local; Female; Humans; Lacerations; Lidocaine, Prilocaine Drug Combination; Obstetric Labor Complications; Ointments; Perineum; Pregnancy; Treatment Outcome
PubMed: 30107755
DOI: 10.1080/14767058.2018.1512576 -
Sexual Medicine Reviews Jan 2019Besides erectile dysfunction, premature ejaculation (PE) is the most frequent male sexual disorder and shows a high level of bother and distress. The negative...
INTRODUCTION
Besides erectile dysfunction, premature ejaculation (PE) is the most frequent male sexual disorder and shows a high level of bother and distress. The negative consequences of long-term and unsuccessfully treated PE on both patient and partner are well established in the literature and include personal distress, impairment of the partner's sexual function, and interpersonal difficulties.
AIM
To outline the consequences of untreated PE and the advantages and disadvantages of currently available treatment options with a special focus on a new topical eutectic lidocaine/prilocaine metered dose spray (Fortacin; Lidocaine/Prilocaine, Recordati, Milan, Italy) which represents the second officially approved drug in this indication.
METHODS
Narrative overview of the literature synthesizing the findings of literature retrieved from searches of computerized databases such as Web of Science, Medline, PubMed, and Google Scholar, hand searches, and authoritative texts. Combinations of keywords including premature ejaculation, ejaculatory control, intravaginal ejaculation latency time, IELT, PE, PDE5 inhibitors (PDE5i), SSRIs, topical anesthetics, lidocaine, prilocaine, and treatment were used. In the end, 59 studies published between 2000 and 2018 were considered relevant for this review.
MAIN OUTCOME MEASURES
Published studies on PE-related negative psychosocial outcomes, as well as advantages and disadvantages of currently available off-label and officially approved treatment options.
RESULTS
Although a variety of treatment options for PE have shown marked improvements in stopwatch-measured intravaginal ejaculation latency time (IELT) and patient-reported outcomes as assessed by the Premature Ejaculation Profile (PEP), none of the investigated drugs has reached market approval. The only so far officially approved medication-dapoxetine-is characterized by high discontinuation rates of up to 90%, mostly because of high side effects, cost issues, efficacy below expectations, and the need for scheduling sexual intercourse.
CONCLUSION
With the official approval in Europe the new dose-metered lidocaine-prilocaine spray (Fortacin) may become a real first-line therapy option for PE and may offer a satisfactory and affordable solution, especially because of its unique galenic preparation, making its handling easy and customer friendly. In addition, it has the potential to significantly increase the currently low patients' acceptance of available monotherapies and become an established second-line therapy for the severe PE patients with IELTs <1 to 2 minutes or with ante-portal ejaculation in combination with oral therapy. Porst H, Burri A. Novel treatment for premature ejaculation in the light of currently used therapies: A review. Sex Med Rev 2019; 7:129-140.
Topics: Benzylamines; Coitus; Ejaculation; Humans; Male; Naphthalenes; Patient Satisfaction; Penile Erection; Phosphodiesterase 5 Inhibitors; Premature Ejaculation; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30057136
DOI: 10.1016/j.sxmr.2018.05.001 -
The Cochrane Database of Systematic... Jul 2018Pain during dental treatment, which is a common fear of patients, can be controlled successfully by local anaesthetic. Several different local anaesthetic formulations... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pain during dental treatment, which is a common fear of patients, can be controlled successfully by local anaesthetic. Several different local anaesthetic formulations and techniques are available to dentists.
OBJECTIVES
Our primary objectives were to compare the success of anaesthesia, the speed of onset and duration of anaesthesia, and systemic and local adverse effects amongst different local anaesthetic formulations for dental anaesthesia. We define success of anaesthesia as absence of pain during a dental procedure, or a negative response to electric pulp testing or other simulated scenario tests. We define dental anaesthesia as anaesthesia given at the time of any dental intervention.Our secondary objective was to report on patients' experience of the procedures carried out.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library; 2018, Issue 1), MEDLINE (OVID SP), Embase, CINAHL PLUS, WEB OF SCIENCE, and other resources up to 31 January 2018. Other resources included trial registries, handsearched journals, conference proceedings, bibliographies/reference lists, and unpublished research.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) testing different formulations of local anaesthetic used for clinical procedures or simulated scenarios. Studies could apply a parallel or cross-over design.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological approaches for data collection and analysis.
MAIN RESULTS
We included 123 studies (19,223 participants) in the review. We pooled data from 68 studies (6615 participants) for meta-analysis, yielding 23 comparisons of local anaesthetic and 57 outcomes with 14 different formulations. Only 10 outcomes from eight comparisons involved clinical testing.We assessed the included studies as having low risk of bias in most domains. Seventy-three studies had at least one domain with unclear risk of bias. Fifteen studies had at least one domain with high risk of bias due to inadequate sequence generation, allocation concealment, masking of local anaesthetic cartridges for administrators or outcome assessors, or participant dropout or exclusion.We reported results for the eight most important comparisons.Success of anaesthesiaWhen the success of anaesthesia in posterior teeth with irreversible pulpitis requiring root canal treatment is tested, 4% articaine, 1:100,000 epinephrine, may be superior to 2% lidocaine, 1:100,000 epinephrine (31% with 2% lidocaine vs 49% with 4% articaine; risk ratio (RR) 1.60, 95% confidence interval (CI) 1.10 to 2.32; 4 parallel studies; 203 participants; low-quality evidence).When the success of anaesthesia for teeth/dental tissues requiring surgical procedures and surgical procedures/periodontal treatment, respectively, was tested, 3% prilocaine, 0.03 IU felypressin (66% with 3% prilocaine vs 76% with 2% lidocaine; RR 0.86, 95% CI 0.79 to 0.95; 2 parallel studies; 907 participants; moderate-quality evidence), and 4% prilocaine plain (71% with 4% prilocaine vs 83% with 2% lidocaine; RR 0.86, 95% CI 0.75 to 0.99; 2 parallel studies; 228 participants; low-quality evidence) were inferior to 2% lidocaine, 1:100,000 epinephrine.Comparative effects of 4% articaine, 1:100,000 epinephrine and 4% articaine, 1:200,000 epinephrine on success of anaesthesia for teeth/dental tissues requiring surgical procedures are uncertain (RR 0.85, 95% CI 0.71 to 1.02; 3 parallel studies; 930 participants; very low-quality evidence).Comparative effects of 0.5% bupivacaine, 1:200,000 epinephrine and both 4% articaine, 1:200,000 epinephrine (odds ratio (OR) 0.87, 95% CI 0.27 to 2.83; 2 cross-over studies; 37 participants; low-quality evidence) and 2% lidocaine, 1:100,000 epinephrine (OR 0.58, 95% CI 0.07 to 5.12; 2 cross-over studies; 31 participants; low-quality evidence) on success of anaesthesia for teeth requiring extraction are uncertain.Comparative effects of 2% mepivacaine, 1:100,000 epinephrine and both 4% articaine, 1:100,000 epinephrine (OR 3.82, 95% CI 0.61 to 23.82; 1 parallel and 1 cross-over study; 110 participants; low-quality evidence) and 2% lidocaine, 1:100,000 epinephrine (RR 1.16, 95% CI 0.25 to 5.45; 2 parallel studies; 68 participants; low-quality evidence) on success of anaesthesia for teeth requiring extraction and teeth with irreversible pulpitis requiring endodontic access and instrumentation, respectively, are uncertain.For remaining outcomes, assessing success of dental local anaesthesia via meta-analyses was not possible.Onset and duration of anaesthesiaFor comparisons assessing onset and duration, no clinical studies met our outcome definitions.Adverse effects (continuous pain measured on 170-mm Heft-Parker visual analogue scale (VAS))Differences in post-injection pain between 4% articaine, 1:100,000 epinephrine and 2% lidocaine, 1:100,000 epinephrine are small, as measured on a VAS (mean difference (MD) 4.74 mm, 95% CI -1.98 to 11.46 mm; 3 cross-over studies; 314 interventions; moderate-quality evidence). Lidocaine probably resulted in slightly less post-injection pain than articaine (MD 6.41 mm, 95% CI 1.01 to 11.80 mm; 3 cross-over studies; 309 interventions; moderate-quality evidence) on the same VAS.For remaining comparisons assessing local and systemic adverse effects, meta-analyses were not possible. Other adverse effects were rare and minor.Patients' experiencePatients' experience of procedures was not assessed owing to lack of data.
AUTHORS' CONCLUSIONS
For success (absence of pain), low-quality evidence suggests that 4% articaine, 1:100,000 epinephrine was superior to 2% lidocaine, 1:100,000 epinephrine for root treating of posterior teeth with irreversible pulpitis, and 2% lidocaine, 1:100,000 epinephrine was superior to 4% prilocaine plain when surgical procedures/periodontal treatment was provided. Moderate-quality evidence shows that 2% lidocaine, 1:100,000 epinephrine was superior to 3% prilocaine, 0.03 IU felypressin when surgical procedures were performed.Adverse events were rare. Moderate-quality evidence shows no difference in pain on injection when 4% articaine, 1:100,000 epinephrine and 2% lidocaine, 1:100,000 epinephrine were compared, although lidocaine resulted in slightly less pain following injection.Many outcomes tested our primary objectives in simulated scenarios, although clinical alternatives may not be possible.Further studies are needed to increase the strength of the evidence. These studies should be clearly reported, have low risk of bias with adequate sample size, and provide data in a format that will allow meta-analysis. Once assessed, results of the 34 'Studies awaiting classification (full text unavailable)' may alter the conclusions of the review.
Topics: Anesthesia, Dental; Anesthetics, Local; Dental Care; Humans; Pain Measurement; Randomized Controlled Trials as Topic
PubMed: 29990391
DOI: 10.1002/14651858.CD006487.pub2 -
The European Journal of Contraception &... Jun 2018Systematic review and meta-analysis to assess the effects of uterine or paracervical lidocaine application on pain control during IUD insertion. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Systematic review and meta-analysis to assess the effects of uterine or paracervical lidocaine application on pain control during IUD insertion.
METHODS
PubMed and five other electronic research databases were searched through 15 November 2017 for RCTs comparing lidocaine treatment vs. a control (placebo or no-intervention) to prevent pain during IUD insertion. Searched terms included 'IUD insertion', 'lidocaine' and 'randomised controlled trial'. RCTs evaluating lidocaine treatment before IUD insertion without restriction of language, age and IUD type. Pain measured by visual pain scales at tenaculum placement, IUD insertion and immediate post-IUD insertion. Results of random effects meta-analyses were reported as mean differences (MDs) of visual pain scale (VPS) scores and their 95% confidence intervals (CIs).
RESULTS
Eleven RCTs (n = 1458 women) reporting paracervical lidocaine block or uterine mucosa lidocaine application before IUD insertion. Lidocaine produced lower VPS scores during tenaculum placement (MD -0.99, 95% CI: -1.73 to -0.26), IUD insertion (MD -1.26, 95% CI: -2.23 to -0.29) and immediate post-IUD insertion period (MD -1.25, 95% CI: -2.17 to -0.33).
CONCLUSION
Lidocaine treatment was associated with modest reduction of pain during tenaculum placement and after IUD insertion.
Topics: Anesthetics, Local; Female; Humans; Intrauterine Devices; Lidocaine; Pain; Pain Measurement; Randomized Controlled Trials as Topic
PubMed: 29792756
DOI: 10.1080/13625187.2018.1469124 -
Journal Der Deutschen Dermatologischen... Mar 2018Local anesthetic cream (LAC) has been used for analgesia in various procedures. However, the analgesic effect of LAC in cryotherapy for warts is unclear. We aimed to... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVE
Local anesthetic cream (LAC) has been used for analgesia in various procedures. However, the analgesic effect of LAC in cryotherapy for warts is unclear. We aimed to evaluate the effects of LAC in cryotherapy for warts.
MATERIAL AND METHODS
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) on the effects of LAC in cryotherapy for warts. We searched MEDLINE, CENTRAL, and EMBASE on 31 March 2017 for relevant RCTs. Two authors independently selected trials, assessed risk of bias, and extracted data. Disagreement was resolved by discussion with a third author.
RESULTS
We included three RCTs with 228 participants. Two included RCTs had a high risk of reporting bias, with one having a high risk of other bias as well. Use of LAC decreased the pain associated with cryotherapy for warts on the hardened skin of children (visual analogue scale, mean difference -20.80, 95 % confidence interval -40.71 to -0.89), but not in adults or on the nonhardened skin of either adults or children.
CONCLUSIONS
The available evidence does not support the routine use of LAC applied for ≤ 60 min in cryotherapy for warts.
Topics: Adult; Anesthetics, Local; Child; Cryotherapy; Humans; Lidocaine, Prilocaine Drug Combination; Pain Measurement; Randomized Controlled Trials as Topic; Warts
PubMed: 29537148
DOI: 10.1111/ddg.13452 -
The Cochrane Database of Systematic... Feb 2017Topical local anaesthetics provide effective analgesia for patients undergoing numerous superficial procedures, including repair of dermal lacerations. The need for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Topical local anaesthetics provide effective analgesia for patients undergoing numerous superficial procedures, including repair of dermal lacerations. The need for cocaine in topical anaesthetic formulations has been questioned because of concern about adverse effects, thus novel preparations of cocaine-free anaesthetics have been developed. This review was originally published in 2011 and has been updated in 2017.
OBJECTIVES
To assess whether benefits of non-invasive topical anaesthetic application occur at the expense of decreased analgesic efficacy. To compare the efficacy of various single-component or multi-component topical anaesthetic agents for repair of dermal lacerations. To determine the clinical necessity for topical application of the ester anaesthetic, cocaine.
SEARCH METHODS
For this updated review, we searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11), Cumulative Index to Nursing and Allied Health Literature (CINAHL; 2010 to December 2016), Embase (2010 to December 2016) and MEDLINE (2010 to December 2016). We did not limit this search by language or format of publication. We contacted manufacturers, international scientific societies and researchers in the field. Weemailed selected journalsand reviewed meta-registers of ongoing trials. For the previous version of this review, we searched these databases to November 2010.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that evaluated the efficacy and safety of topical anaesthetics for repair of dermal laceration in adult and paediatric participants.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information when needed. We collected adverse event information from trial reports. We assessed methodological risk of bias for each included study and employed the GRADE approach to assess the overall quality of the evidence.
MAIN RESULTS
The present updated review included 25 RCTs involving 3278 participants. The small number of trials in each comparison group and the heterogeneity of outcome measures precluded quantitative analysis of data for all but one outcome: pain intensity. In two pooled studies, the mean self-reported visual analogue scale (VAS; 0 to 100 mm) score for topical prilocaine-phenylephrine (PP) was higher than the mean self-reported VAS (0 to 100 mm) score for topical tetracaine-epinephrine-cocaine (TAC) by 5.59 points (95% confidence interval (CI) 2.16 to 13.35). Most trials that compared infiltrated and topical anaesthetics were at high risk of bias, which is likely to have affected their results. Researchers found that several cocaine-free topical anaesthetics provided effective analgesic efficacy. However, data regarding the efficacy of each topical agent are based mostly on single comparisons in trials with unclear or high risk of bias. Mild, self-limited erythematous skin induration occurred in one of 1042 participants who had undergone application of TAC. Investigators reported no serious complications among any of the participants treated with cocaine-based or cocaine-free topical anaesthetics. The overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached.
AUTHORS' CONCLUSIONS
We have found two new studies published since the last version of this review was prepared. We have added these studies to those previously included and have conducted an updated analysis, which resulted in the same review conclusions as were presented previously.Mostly descriptive analysis indicates that topical anaesthetics may offer an efficacious, non-invasive means of providing analgesia before suturing of dermal lacerations. Use of cocaine-based topical anaesthetics might be hard to justify, given the availability of other effective topical anaesthetics without cocaine. However, the overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached.
Topics: Adult; Anesthetics, Local; Child; Cocaine; Drug Combinations; Epinephrine; Humans; Lacerations; Pain Measurement; Randomized Controlled Trials as Topic; Skin; Sutures; Tetracaine
PubMed: 28230244
DOI: 10.1002/14651858.CD005364.pub3 -
The Cochrane Database of Systematic... Oct 2016Randomised controlled trials (RCTs) show that breastfeeding newborn infants during painful procedures reduces pain. Mechanisms are considered to be multifactorial and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Randomised controlled trials (RCTs) show that breastfeeding newborn infants during painful procedures reduces pain. Mechanisms are considered to be multifactorial and include sucking, skin-to-skin contact, warmth, rocking, sound and smell of the mother, and possibly endogenous opiates present in the breast milk.
OBJECTIVES
To determine the effect of breastfeeding on procedural pain in infants beyond the neonatal period (first 28 days of life) up to one year of age compared to no intervention, placebo, parental holding, skin-to-skin contact, expressed breast milk, formula milk, bottle feeding, sweet-tasting solutions (e.g. sucrose or glucose), distraction, or other interventions.
SEARCH METHODS
We searched the following databases to 18 February 2016: the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE including In-Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (apps.who.int/trialsearch/) for ongoing trials.
SELECTION CRITERIA
We included RCTs and quasi-RCTs involving infants aged 28 days postnatal to 12 months and receiving breastfeeding while undergoing a painful procedure. Comparators included, but were not limited to, oral administration of water, sweet-tasting solutions, expressed breast or formula milk, no intervention, use of pacifiers, positioning, cuddling, distraction, topical anaesthetics, and skin-to-skin care. Procedures included, but were not limited to: subcutaneous or intramuscular injection, venipuncture, intravenous line insertion, heel lance, and finger lance. We applied no language restrictions.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data. The main outcome measures were behavioural or physiological indicators and composite pain scores, as well as other clinically important outcomes reported by the authors of included studies. We pooled data for the most comparable outcomes and where data from at least two studies could be included. We used mean difference (MD) with 95% confidence interval (CI), employing a random-effects model for continuous outcomes measured on the same scales. For continuous outcomes measured on different scales, we pooled standardised mean differences (SMDs) and associated 95% CIs. For dichotomous outcomes, we planned to pool events between groups across studies using risk ratios (RRs) and 95% CIs. However, as insufficient studies reported dichotomous outcomes, we did not pool such events. We assessed the evidence using GRADE and created a 'Summary of findings' table.
MAIN RESULTS
We included 10 studies with a total of 1066 infants. All studies were conducted during early childhood immunisation. As the breastfeeding intervention cannot be blinded, we rated all studies as being at high risk of bias for blinding of participants and personnel. We assessed nine studies as being at low risk of bias for incomplete outcome data. In addition, we rated nine studies as high risk for blinding of outcome assessment. We scored risk of bias related to random sequence generation, allocation concealment, and selective reporting as unclear for the majority of the studies due to lack of information.Our primary outcome was pain. Breastfeeding reduced behavioural pain responses (cry time and pain scores) during vaccination compared to no treatment, oral water, and other interventions such as cuddling, oral glucose, topical anaesthetic, massage, and vapocoolant. Breastfeeding did not consistently reduce changes in physiological indicators, such as heart rate. We pooled data for duration of cry from six studies (n = 547 infants). Breastfeeding compared to water or no treatment resulted in a 38-second reduction in cry time (MD -38, 95% CI -50 to -26; P < 0.00001). The quality of the evidence according to GRADE for this outcome was moderate, as most infants were 6 months or younger, and outcomes may be different for infants during their 12-month immunisation. We pooled data for pain scores from five studies (n = 310 infants). Breastfeeding was associated with a 1.7-point reduction in standardised pain scores (SMD -1.7, 95% CI -2.2 to -1.3); we considered this evidence to be of moderate quality as data were primarily from infants younger than 6 months of age. We could pool heart rate data following injections for only two studies (n = 186); we considered this evidence to be of low quality due to insufficient data. There were no differences between breastfeeding and control (MD -3.6, -23 to 16).Four of the 10 studies had more than two study arms. Breastfeeding was more effective in reducing crying duration or pain scores during vaccination compared to: 25% dextrose and topical anaesthetic cream (EMLA), vapocoolant, maternal cuddling, and massage.No included studies reported adverse events.
AUTHORS' CONCLUSIONS
We conclude, based on the 10 studies included in this review, that breastfeeding may help reduce pain during vaccination for infants beyond the neonatal period. Breastfeeding consistently reduced behavioural responses of cry duration and composite pain scores during and following vaccinations. However, there was no evidence that breastfeeding had an effect on physiological responses. No studies included in this review involved populations of hospitalised infants undergoing other skin-breaking procedures. Although it may be possible to extrapolate the review results to this population, further studies of efficacy, feasibility, and acceptability in this population are warranted.
Topics: Anesthetics, Local; Breast Feeding; Crying; Female; Glucose; Heart Rate; Humans; Infant; Infant Care; Lidocaine; Lidocaine, Prilocaine Drug Combination; Massage; Pain; Pain Management; Pain Measurement; Prilocaine; Randomized Controlled Trials as Topic; Time Factors; Vaccination
PubMed: 27792244
DOI: 10.1002/14651858.CD011248.pub2